Probiotics in Newly Diagnosed T1D

Medical College of Wisconsin

Status and phase: Active, not recruiting; Phase 2

Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes; Type1diabetes

Treatments: Other: Placebo; Dietary Supplement: Visbiome

Study type: Interventional

Funder types: Other

Identifiers

NCT04141761

1343363

Details and patient eligibility

About

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Enrollment: 43 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must meet all of the following criteria:

  1. Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
  2. Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
  3. Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
  4. Treatment naïve of any immunomodulatory agent

Exclusion criteria

• Patients must NOT meet any of the following criteria:

  1. Probiotic use within 1 month of screening visit
  2. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
  3. Diabetes other than T1D
  4. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
  5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Treatment:

Dietary Supplement: Visbiome

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo